Advanced Cardiac Imaging To Predict Embolic Stroke On Brain MRI: A Pilot Study

NCT04769310 | Completed FDA Device

• 1 other identifier: 2020-2151
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Demonstrating the pathophysiological link between Left Atrial (LA) and Left Atrial Appendage (LAA) pathology and embolic strokes in non-Atrial Fibrillation (AF) individuals represents a major advance in stroke prevention strategies. Instead of relying on non-specific criteria for stroke risk assessment, the investigators propose to identify individuals with high-risk of embolic stroke using imaging criteria that reflect the underlying pathophysiology of embolic stroke of cardiac origin. the investigators can therefore lay the groundwork for future anticoagulation strategies for stroke prevention beyond AF.

Conditions

Atrial Fibrillation; Stroke; Stroke, Cardiovascular; Vascular Cognitive Impairment; Strokes Thrombotic; Stroke, Ischemic

Keywords

Magnetic Resonance Imaging; Cardiac Magnetic Resonance Imaging; Brain infarcts; Left atrial; Left atrial appendage; Non invasive cardiac imaging

Outcome Measures

Primary Outcomes (1)

• The presence of covert embolic cerebral infarcts

  The covert embolic cerebral infarcts are defined as the presence of asymptomatic non-lacunar embolic infarct (acute or chronic based on MRI appearance), in the cortex, and juxtacortical regions, and cerebellum. They will be identified using brain MRI.

  Day1

Secondary Outcomes (3)

• Number of counts of lacunar covert infracts

  Day1

• Number of counts of lacunar symptomatic infracts

  Day1

• Number of counts of embolic symptomatic infracts

  Day1

Study Arms (1)

Patient arm

OTHER

All patients will undergo a CMR to evaluate for LA and LAA high-risk features on either a 1.5 or 3 Tesla clinical MR scanner. Gadolinium injection will be administered. Gadolinium is a contrast product that helps define areas of fibrosis in the LA. High-resolution brain MRI with no contrast will include the following sequences for most accurate assessment of embolic lesions: 3D T1 MPRAGE, 3D FLAIR, DWI, ADC, and SWI

Device: Cardiac and Brain MRI

Interventions

Cardiac and Brain MRI DEVICE

A CMR to evaluate for LA and LAA high-risk features on either a 1.5 or 3 Tesla clinical MR scanner will be used. Gadolinium injection will be administered. Gadolinium is a contrast product that helps define areas of fibrosis in the LA. High-resolution brain MRI with no contrast will include the following sequences for most accurate assessment of embolic lesions: 3D T1 MPRAGE, 3D FLAIR, DWI, ADC, and SWI

Patient arm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients
• Years and older
• No history of atrial fibrillation
• CHA2DS2VASC score ≥3
• History pf type II diabetes
• History of congestive heart failure or a history of transient ischemic attack (TIA)/stroke without an otherwise defined stroke etiology such as large vessel or small vessel disease

You may not qualify if:

• History of atrial fibrillation
• Patients who had a clinically symptomatic acute stroke within the last 30-days
• Any health-related gadolinium/MRI contraindication (including previous allergic reaction to Gadolinium, pacemakers, defibrillators, other devices/implants contraindicated for MRI)
• Estimated glomerular filtration rate (eGFR) cutoff in patients with Chronic kidney disease (CKD) where gadolinium cannot be used equals an eGFR \<30 ml/min
• Weighing \> 300 lbs (as CMR image quality decreases due to increased body mass index)
• Current pregnancy or breastfeeding
• Cognitive impairment preventing the patient from giving an informed consent

Sponsors & Collaborators

• Tulane University: lead

Study Sites (1)

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

Location

Related Publications (31)

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MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Myocardial Infarction; Thrombotic Stroke; Ischemic Stroke; Brain Infarction

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Myocardial Ischemia; Infarction; Ischemia; Necrosis; Brain Ischemia

Study Officials

• Nassir Marrouche, MD

  Tulane School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients will undergo a CMR to evaluate for LA and LAA high-risk features on either a 1.5 or 3 Tesla clinical MR scanner. CMR protocol will include Cine MRI, contrast-enhanced (CE) MR Angiography (MRA), time-resolved 2D phase-contrast (PC) MRI, and 3D late gadolinium enhancement (LGE) involving gadolinium injection. Gadolinium is a contrast product that helps define areas of fibrosis in the LA. Brain MRI will be used for the detection of embolic infarcts assessed on high-resolution brain MRI acquisitions. The high-resolution brain MRI with no contrast will include the following sequences for most accurate assessment of embolic lesions: 3D T1 Magnetization Prepared Rapid Acquisition Gradient Echo (MPRAGE), 3D fluid attenuated inversion recovery (FLAIR), diffusion weighted imaging (DWI), apparent diffusion coefficient maps (ADC), and susceptibility weighted imaging (SWI).

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 24, 2021
• Study Start: April 26, 2021
• Primary Completion: January 27, 2026
• Study Completion: January 27, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)